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A Study of the Effects of CY6463 in Participants With Alzheimer's Disease With Vascular Pathology
A Phase 2a Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CY6463 When Administered to Participants With Alzheimer's Disease and Vascular Pathology
Lead sponsor
Asset
CY6463
Listed sites
5
Recruiting sites
-
Enrollment
12
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE 20-26
Primary endpoint
•Treatment-emergent Adverse Events (TEAEs) From Study Drug Initiation Through
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Provide written informed consent prior to the performance of any protocol-specified procedure or, if unable to provide informed consent due to cognitive status, provides assent to participate, with a legally authorized representative (LAR) providing written informed consent on behalf of the participant.
2. 60 years of age or older
3. Meets core clinical criteria for probable AD dementia according to the 2011 National Institute on Aging-Alzheimer's Associated guidelines. Can be based on medical history.
4. Mini-Mental State Examination (MMSE) score of 20 to 26 (inclusive)
5. Confirmation of AD pathophysiology
6. At least 2 cardiovascular risk factors per protocol criteria
7. Magnetic resonance imaging (MRI) scan (existing MRI obtained ≤6 months before Screening is acceptable) findings of mild-to-moderate subcortical small-vessel disease
8. If receiving concomitant or chronic medication(s), has had no change for ≥4 weeks before study drug initiation and has no plans to alter the regimen(s) during the study
9. If male, agrees to refrain from donating sperm from the Screening visit through 90 days after taking the final study drug dose
10. If male, agrees to use protocol-specified, effective contraception methods from the signing of the informed consent form (ICF) until ≥90 days after taking the final study drug dose.
11. If female, is postmenopausal/not of reproductive potential defined per protocol
12. Agrees to the study procedures, including undergoing lumbar puncture for cerebrospinal fluid (CSF) samples
Exclusion criteria
1. Severe visual, auditory, social, or cognitive impairment
2. Dementia-related disorder other than AD or vascular dementia (eg, Parkinson's disease, Huntington's disease, frontotemporal dementia, schizophrenia, Lewy body dementia)
3. Symptomatic large-vessel disease, symptomatic carotid artery disease, large vessel infarcts, or strategic lacunar infarcts or infarcts>15 mm
4. History of significant central nervous system (CNS) trauma that has affected brain function
5. Low blood pressure (BP), defined as systolic BP ≤90 mmHg or diastolic BP ≤60 mmHg.
6. Orthostatic hypotension.
7. Unable to undergo MRI
8. Unable to undergo lumbar puncture procedure
9. Unable to participate in electroencephalography (EEG) protocol due to hearing impairment or inability to tolerate EEG cap or headphones
10. Uncontrolled or unstable chronic disease
11. Kidney impairment requiring dialysis; history of renal transplant
12. Needs continuous direct medical care and nursing supervision.
13. Family history of short QT syndrome or long QT syndrome
14. Clinically significant cardiac involvement
15. History of cancer. Exceptions: localized cutaneous basal or squamous cell carcinoma in the last 5 years, low-grade localized prostate/cervical cancers, or previous localized prostate/cervical cancers that have a low likelihood of recurrence
16. Is not suited for study participation in the clinical judgment of the investigator
Additional inclusion and exclusion criteria apply, per protocol.
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
2 endpointsIncidence of Treatment-emergent Adverse Events (TEAEs) From Study Drug Initiation Through Follow-up
Time frame:From first dose of study treatment through ~14 (±4) days after the final dose
event count, event
Incidence of Treatment-emergent Adverse Events (TEAEs) From Study Drug Initiation Through Follow-up
Time frame:From first dose of study treatment through ~14 (±4) days after the final dose
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Placebon=6 Participants | 0 | - |
| CY6463n=6 Participants | 2 | - |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.